Symproic (naldemedine)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved March 2017

Specific Treatments:

opioid-induced constipation

Therapeutic Areas

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General Information

Symproic (naldemedine) is an opioid antagonist.

Symproic is specifically indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Symproic is supplied as a tablet for oral administration. The recommended dosage is 0.2 mg once daily with or without food.

Clinical Results

FDA Approval

The FDA approval of Symproic was based on two replicate, 12-week, randomized, double-blind, placebo-controlled trials (Study 1 and Study 2) in which Symproic was used without laxatives in patients with OIC and chronic non-cancer pain. In both studies, OIC was confirmed through a two-week run in period and was defined as no more than 4 spontaneous bowel movements (SBMs) total over 14 consecutive days and less than 3 SBMs in a given week with at least 25% of the SBMs associated with one or more of the following conditions: (1) straining; (2) hard or lumpy stools; (3) having a sensation of incomplete evacuation; and (4) having a sensation of anorectal obstruction/blockage. A total of 547 patients in Study 1 and 553 patients in Study 2 were randomized in a 1:1 ratio to receive Symproic 0.2 mg once daily or placebo for 12 weeks. Study medication was administered without regard to meals. The efficacy of Symproic was assessed in Studies 1 and 2 using a responder analysis. A responder was defined as a patient who had at least 3 SBMs per week and a change from baseline of at least 1 SBM per week for at least 9 out of the 12 weeks and 3 out of the last 4 weeks in Studies 1 and 2. Study 1: Symproic arm: 130 subjects (48%) were responders versus placebo arm: 94 subjects (35%) (p=0.0020). Study 2: Symproic arm: 145 subjects (53%) were responders versus placebo arm: 92 subjects (34%) (p<0.0001).

Side Effects

Adverse effects associated with the use of Symproic may include, but are not limited to, the following:

  • abdominal pain
  • diarrhea
  • nausea

Mechanism of Action

Symproic (naldemedine) is an opioid antagonist with binding affinities for mu-, delta-, and kappa-opioid receptors. Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. 

Additional Information

For additional information regarding Symproic or opioid-induced constipation, please visit http://www.shionogi.com/